A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment
Sponsor study identifier
Secondary identifiers
interventional
3,834
0 countries
N/A
Study Start
December 19, 2001
Actual (reported)Primary Completion
March 31, 2009
Actual (reported)Study Completion
May 13, 2009
Actual (reported)This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 13, 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2001
Actual (reported)August 25, 2004
Actual (reported)August 27, 2004
Actual (reported)March 31, 2009
Actual (reported)May 13, 2009
Actual (reported)August 2, 2010
Actual (reported)Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure
Entire follow-up (median = 4.7 years)
Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization
Entire follow-up (median = 4.7 years)
Number of Participants That Died (Any Cause)
Entire follow-up (median = 4.7 years)
Number of Participants That Were Hospitalized for Heart Failure
Entire follow-up (median = 4.7 years)
Number of Participants That Experienced Cardiovascular Hospitalization
Entire follow-up (median = 4.7 years)
50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years)
Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan
50-mg losartan oral tablet
100-mg losartan oral tablet + 50-mg losartan oral tablet
Contact the study team to confirm eligibility.
Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.
Rossignol P, Girerd N, Gregory D, Massaro J, Konstam MA, Zannad F. Increased visit-to-visit blood pressure variability is associated with worse cardiovascular outcomes in low ejection fraction heart failure patients: Insights from the HEAAL study. Int J Cardiol. 2015;187:183-9. doi: 10.1016/j.ijcard.2015.03.169. Epub 2015 Mar 17.
Medical Monitor
Merck Sharp & Dohme LLC
3,834 participants (actual enrollment reported by the registry).
First Submitted
August 25, 2004
First Posted
August 27, 2004
Study Start
December 19, 2001
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kiernan MS, Gregory D, Sarnak MJ, Rossignol P, Massaro J, Kociol R, Zannad F, Konstam MA. Early and late effects of high- versus low-dose angiotensin receptor blockade on renal function and outcomes in patients with chronic heart failure. JACC Heart Fail. 2015 Mar;3(3):214-23. doi: 10.1016/j.jchf.2014.11.004.
Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840-8. doi: 10.1016/S0140-6736(09)61913-9. Epub 2009 Nov 16.
Primary Completion
March 31, 2009
Actual (reported)Study Completion
May 13, 2009
Actual (reported)Last Updated
May 16, 2024
Results First Posted
August 2, 2010
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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